CMC Regulatory Affairs Specialist

3 weeks ago


Dublin, Ireland Regeneron Pharmaceuticals, Inc Full time

The CMC Regulatory Affairs Specialist  is responsible for for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and procedures to determine regulatory impact. ​

E ssential Duties and Responsibilities include, but are not limited to, the following:

* Plans and conducts critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, and supplements to ensure a high quality regulatory submission and approval.

* Reviews Change Controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and ensures that CMC related changes are reported to competent authorities in accordance with regulatory requirements, as necessary.

* Tracks and/or completes CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs.

* Provides CMC-related mentorship to IOPS so that their short-term and long-term goals are achieved on time and with highest quality.

* Participates in CMC project team meetings and provides current regulatory requirements that pertain to stability studies and analytical characterization tests.

E ducation and Experience:

• Requires BS/BA in Chemistry, Biology or related field (advanced degree preferred).

• 2+ years of experience working in the biopharmaceutical manufacturing or related industry including experience in regulatory or compliance related activities.



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